FDA Drug Judge Outsted

ByVictor Cohn

March 29, 1980

The Food and Drug Administration has removed from his job, at least temporarily, its leading judge of generic drugs.

A Tennessee congressman and a former New York Assembly drug industry prober called yesterday for an investigation, saying the FDA official, Dr. Marvin Seife, was being punished for his advocacy of generic drugs during years of FDA footdragging. Generic drugs are cheaper, non-brand-name versions of prescription drugs.

The FDA said five employes in its division of generic drug monographs -- important summaries of drug worthness -- have been "detailed to other jobs" pending an investigation of possible violations of conduct.

"Under the privacy act," the FDA said, no names were being released. But the five, an agency official conceded, were Seife, the division chief and four persons who worked under him.

Among allegations against them, the FDA said, were "going to lunch as guests of regulated industry," a violation unless the meal is part of a scheduled meeting, and improperly speeding up "certain drug firms' applications."

Seife is far from a special pleader for drugmakers, maintained his defenders, Rep. Albert Gore Jr. (D-Tenn.) and William Haddad, former director of the New York State Assembly committee whose work led to New York and other state laws ordering pharmacists to fill prescriptions with the cheapest acceptable drugs unless a doctor specified a name brand.

Haddad said that "without Seife's help," and cooperation in the face of opposition by other FDA officials, "no generic drug law would have been passed in any state."

Gore, leading prescription drug investigator on the House oversight and investigation subcommittee, said "I assume" the action against Seife "is in retribution for his recent testimony before us."

A year and a half ago, Seife told Congress that some major drug firms were deceiving patents and doctors by selling, under their own higher priced labels, cheap drugs made for them by generic manufacturers.

This month he told the oversight subcommittee that the FDA still has not made final a regulation it proposed in October 1978, one requiring full disclosure of the plant site where a brand-name drug is made.